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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER

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STRAUB MEDICAL AG ROTAREXS 6F 135CM (STRAUB MEDICAL) ATHERECTOMY CATHETER Back to Search Results
Model Number SET ROTAREX®S 6F X 135CM
Device Problems Fracture (1260); Device Slipped (1584); Difficult to Advance (2920); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problems Hyperplasia (1906); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
Suspect device not returned yet. The return of suspect device is expected.
 
Event Description
Rcfa access with 6f 65cm terumo destination sheath placed in lcfa for diagnostic imaging. Bifurcation met the requirements of 2cm radius and physician reported no difficulty in placing the sheath up and over. Angiogram showed narrowing of a previously placed supera stent in the distal lsfa with a cto just distal to the stent that extended to the mid l popliteal artery. Ivus showed disease from the proximal tp trunk through the cto that extended proximally to about 6cm proximal to the supera stent. Physician asked about rtx, myself and (b)(4) mentioned to him that we have a contraindication for isr and that we prefer to work with vessels larger than 3mm and non btk arteries, but he wished to proceed anyways. Rtx wire placed about 18 inches distal to the target vessel near the patients ankle, rtx was prepped and delivered to 1 inch above the lesion and we began atherectomy. After approx. 2 mins of use, we noticed that the clutch appeared to have slipped while atherectomizing inside the stent, so we disengaged the motor, retracted the device and reengaged after several seconds. Used a bite and chew method until we reached midstent, at which point rtx would not advance further. After several attempts to cross beyond this point, we decided to abort atherectomy and balloon the lesion. Physician removed the catheter and stepped on fluoro for a "spot check" and we noticed that the beveled head and a length on the helix remained in the lsfa. Physician pulled the wire back and the helix came with the wire until it was almost encapsulated by the procedural sheath, at which point he pulled the sheath back to the arteriotomy. At this point, nearly the entire portion of the helix that had fractured was inside our procedural sheath and the beveled tip was just outside of the sheath in the rcfa we were unable to get the tip to come back into the sheath after several attempts and different techniques. The stent did not seem to be compressed externally, rather it seemed as if neointimal hyperplasia had occurred which caused a re-narrowing of the stent. The stent appeared to be about 60/80mm long. The stent was not occluded, there was an occlusion distal to the stent, no occlusion proximal. He did not work in a vessel under 3mm. Rtx wire was a straub guidewire. Rotarex 6f 135cm used. Tip of wire was 18 inch distal to lesion when the device was used. He started to work in the stent and stopped mid of stent, probably because of the cto. There was not cto in stent. Everything has been successfully removed from the patient. Appeared to be about 50cm.
 
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Brand NameROTAREXS 6F 135CM (STRAUB MEDICAL)
Type of DeviceATHERECTOMY CATHETER
Manufacturer (Section D)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ 7323
Manufacturer (Section G)
STRAUB MEDICAL AG
straubstrasse 12
wangs, sankt gallen 7323
SZ 7323
Manufacturer Contact
martin kvokacka
straubstrasse 12
wangs, sankt gallen 7323
SZ   7323
MDR Report Key10383787
MDR Text Key233714184
Report Number3008439199-2020-00033
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSET ROTAREX®S 6F X 135CM
Device Catalogue Number80237
Device Lot Number200664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2020 Patient Sequence Number: 1
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